FDA 510(k) Application Details - K012155

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K012155
Device Name System, Image Processing, Radiological
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650-1131 US
Other 510(k) Applications for this Company
Contact ANNE ZAVERTNIK
Other 510(k) Applications for this Contact
Regulation Number 892.2050

  More FDA Info for this Regulation Number
Classification Product Code LLZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/11/2001
Decision Date 08/10/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact